BroPair Spiromax (salmeterol;fluticasone propionate)
- Region
- 🇪🇺 EU
- Active substance
- salmeterol;fluticasone propionate
- Company
- Teva B.V.
- Status
- Withdrawn
- Therapeutic area
- Asthma
- CHMP opinion
- Thu 28 Jan 2021
- EU approval
- Fri 26 Mar 2021
- Application
- EMEA/H/C/005591
- ATC
- R03AK06
- Official record
- www.ema.europa.eu
Indication
BroPair Spiromax is indicated in the regular treatment of asthma in adults and adolescents aged 12 years and older not adequately controlled with inhaled corticosteroids and ‘as needed’ inhaled short-acting ?? agonists.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Seffalair Spiromax Authorised · Teva B.V.
- 🇪🇺 Aerivio Spiromax Withdrawn · Teva B.V.
Follow BroPair Spiromax
Get VigiEye Daily: approvals, opinions, safety actions and PDUFA dates every morning.
Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.